Virtual Reality Distraction During Outpatient Pediatric Orthopedic Procedures
Virtual Reality(VR) has had promising applications in science and medicine, including intervention delivery. The use of VR interventions has been studied in a wide range of medical conditions, including anxiety, phobias, obesity, chronic pain, and eating disorders. VR based simulation in pediatrics has grown rapidly in recent years and is expected to continue to grow. VR technology has become increasingly affordable, flexible, and portable, enabling its use in a broad range of environments including the outpatient clinical setting. Additionally, children are believed to have an inclination toward games of "pretend" or alternate realities further indicating the potential of this technology. While immersed in a game, they often become deeply absorbed and able to ignore aversive stimuli. VR is an engaging intervention that may help to detract from pain and anxiety for children undergoing painful procedures. Heart rate has been used as a means to objectively quantify the physiologic response to pain and anxiety. The purpose of the study is to conduct a randomized controlled study that assess the utility of Virtual Reality simulations compared to non immersive visual distraction in pediatric patients undergoing outpatient procedures including cast removal and surgical suture/pins removal. Primary outcomes will include changes in patient heart rate (an age-validated surrogate for pain and anxiety) and patient-reported changes in anxiety and pain. Secondary outcomes will include patient/parent-reported satisfaction.
Conditions:
🦠 Fractures, Bone 🦠 Deformity; Bone
🗓️ Study Start (Actual) 25 July 2018
🗓️ Primary Completion (Estimated) 24 July 2023
✅ Study Completion (Estimated) 24 July 2023
👥 Enrollment (Estimated) 226
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • -All patients pediatric patients undergoing cast, pin and suture removal between the ages of 4 -14 years

    Exclusion Criteria:

    • * History of epilepsy and seizures
    • * Anxiety disorders documented
    • * Unable to understand/follow VR directions
    • * History of vertigo and/or dizziness
    • * History of chronic pain
    • * Non-English speakers
Ages Eligible for Study: 4 Years to 14 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 18 August 2022
  • First Submitted that Met QC Criteria 18 August 2022
  • First Posted 22 August 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 18 August 2022
  • Last Update Posted 22 August 2022
  • Last Verified August 2022